Club foot is a serious birth defect found worldwide and effective treatment may take up to 3 years. This disorder is treated in a variety of ways. One of the most clinically accepted and successful treatments, termed the Ponseti Method, requires incremental readjustment of the feet with castings, followed by using a brace or other stabilizing devices to maintain abduction of the foot. Current stabilizing devices include a Denis Browne splint that is secured to special shoes that are worn by children afflicted with this condition and other related conditions of the foot and legs. The Denis Browne splint or “night splint” must often times be worn all night and throughout the day. While it has been proven to be effective in realigning children's feet and helping them gain a normal level of functionality, the device is somewhat cumbersome and inconvenient to use. As such, non-compliance with the treatment may result.
For example, many caregivers have reported that the current Denis Browne Splint is difficult to put on and is problematic when performing tasks such as changing diapers, putting the child in a car seat, putting the child to sleep, and changing clothes. While performing these tasks the child often experiences discomfort, making the removal and reattachment of the splint more taxing to the caregiver as well. As a result, caregivers tend to allow the child to forego using the splint during these tasks due to these inconveniences and discomforts, thus deviating from the prescribed regimen. Subsequently the duration of the therapy must be prolonged or the child may relapse or regress, restricting the child from the full benefit of the treatment.
A typical Denis Browne splint comprises a rigid bar adapted to be connected between the feet of a patient, and means at either end of the bar for attachment to the patient's feet, maintaining the feet in the desired relationship to each other. The rigid bar may be attached to the patient's shoes by various means. In some instances, plates are permanently attached to the bar and attached to the soles of the shoes by screws. The system of bars and plates requires maintaining the desired adjustment while the screws which attach the plates to the bar are tightened to the sole of the shoe with tools. This may make accurate adjustment somewhat difficult. Consequently, once the adjustment is made, it is usually maintained, and the removal and replacement of the splint requires the removal and replacement of the patient's feet from the shoes while the shoes stay attached to the splint.
Another system for attachment of the bar to the patient's feet requires the use of clamps which clamp the sides of the sole of the shoe. The clamps may be detached from the shoes without disturbing the adjustment of the splint, but it is difficult to reattach the splint to the shoes in the exact relationship desired.
Another system for attachment of the bar to the patient's feet requires sliding engagement of clip means with a track formed by ribs in a shoe clip means, the shoe clip means being fixed to a articulated joint for releasable rigid attachment. Although the shoes may be attached to and detached from the splint by means of the clip means and shoe clips, it may be necessary to extend the patient's legs forward in order to insert the shoe clip means into the track of the clip means. This extension of the leg and foot may be difficult for the caregiver and uncomfortable for the patient. Moreover, the track assembly may not provide sufficient stability to the assembly which may result in excess play and rattle of the shoe and splint. As a result, non-compliance with a corrective foot orthotic treatment may result with the aforementioned systems.
Certain conditions of the lower extremities require the maintenance of either of plantar (toe down) or dorsi (toe up) flexion on one or both feet. The ordinary Denis Browne splints may not be capable of correcting such conditions, and while other devices exist for these conditions, using them in addition to the Denis Browne splint is difficult. Consequently, it is difficult to correct some of the more complex deformities.